ISO 14971 Medical Device and IVD Risk/Benefit Analysis

Medical device manufacturing is a risky business. When things go wrong with a medical device, there is a lot at stake. At the very least, it can be expensive and disruptive for your company. At the worst, it can cause patient injury or even death.

So how do you evaluate and manage risk? ISO 14971 standardizes risk management procedures and protocols for medical device manufacturers. In this white paper, we’ll take a deep dive into risk/benefit analysis, ISO 14971 requirements, and much more, including:

How does ISO 14971 define risk/benefit analysis?

What are the differences between ISO 14971:2007 and EN ISO 14971:2012?

What is a data/literature review?

What are some examples of quantitative risk/benefit methodologies?

Learn all this and more in this 9-page white paper.

About the Author

Michael Dun, RAC: Michael Dun is the Australia Country Manager and Director at Emergo. He has more than 13 years of experience in quality systems, auditing, regulatory affairs, and research and development across the biotechnology, IVD and medical device manufacturing and services industries. His areas of expertise include QMS implementation and audits, risk management, and device registration and documentation in the US, EU, Brazil, and Australia.

Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Learn more here.